Ovarian Neoplasm ; Psychological DistressNCT06813001
ACT-Based Nursing Intervention for Ovarian Cancer Patients: A Pilot Study
A study testing ACT-based nursing intervention in people with Ovarian Neoplasm ; Psychological Distress, run by Yonsei University.
Trial summary
The purpose of this study is to evaluate the feasiblity and effectiveness of an Acceptance and Commitment Therapy (ACT)-based nursing intervention aimed at managing psychological flexibility, distress, anxiety, depression, fear of cancer recurrence/progression, quality of life, and symptoms. Read more about this study
- Who is it for?
- Ages 19 to 75 years, women only
- Conditions the study is for
- Ovarian Neoplasm ; Psychological Distress
- What is being tested?
- ACT-based nursing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (19 ≤ age ≤ 75).
- ovarian cancer patients with FIGO stage 2-3.
- Those who have completed first-line chemotherapy for ovarian cancer (excluding maintenance therapy) within the past 2 years.
Who cannot join
- Patients with cognitive problems such as dementia or psychiatric problems such as major depression or generalized anxiety, or who are actively receiving treatment for any of these conditions.
- Patients with history of cancer recurrence.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of ACT (Acceptance and Commitment Therapy)-Based Nurse-led Intervention for Ovarian Cancer Patients
The purpose of this study is to evaluate the feasiblity and effectiveness of an Acceptance and Commitment Therapy (ACT)-based nursing intervention aimed at managing psychological flexibility, distress, anxiety, depression, fear of cancer recurrence/progression, quality of life, and symptoms. Patients will participate in a single online session with a nurse, followed by a daily self-monitoring survey online for one week. Data will be collected at baseline (prior to the ACT session), on day 8 (after one week of self-monitoring), and at 5 weeks. Primary outcome is psychological flexibility.
Read the detailed description
This study is a preliminary single-group pre-post design aimed at developing and evaluating the feasibility of an ACT-based nursing intervention for distress management in patients with ovarian cancer. A total of 25 ovarian cancer patients who consent to participate will be enrolled in the study. Paticipants will receive a one-time ACT-based nursing intervention lasting approximately 60 minutes.
The researcher will coordinate schedules with participants to deliver the ACT-based nursing intervention using Zoom, a video conferencing platform which minimizes time and location constraints. Before the intervention, the research will ensure that the participants' video conferencing is working properly to minimize potential difficulties during the session.
Following the single-session intervention, the researcher will send a daily Google Form link to participants for seven consecutive days. Participants will be encouraged to access the link and complete self-monitoring surveys to reinforce the key components addressed in the program.
- Being tested
- ACT-based nursing intervention
- Keywords
- Ovarian Neoplasms, Psychological Distress, Acceptand and Commitment Therapy (ACT), Nursing intervention
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-based nursing interventionOther
ACT-based nursing intervention is a 1:1 single online session with a nurse, which takes about 60 minutes followed by a daily self-monitoring survey for one week, which encourages patients to practice ACT.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Experimental group with application of ACT-based nursing intervention Receives: Other: ACT-based nursing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline psychological distress on the last day of self-monitoring (Day 8)
Psychological distress measured by Distress Thermometer.
Measured: Psychological distress will be assessed at baseline and on the last day of self-monitoring (Day 8).
Secondary outcomes (6)
Change from baseline depression
depression measured by the Hospital Anxiety and Depression Scale (HADS).
Measured: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from anxiety
Anxiety by the Hospital Anxiety and Depression Scale (HADS).
Measured: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from fear of cancer recurrence
Fear of cancer recurrence measured by the Fear of Cancer Recurrence Index (FCRI).
Measured: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from psychological flexibility
Psychological flexibility measured by the Acceptance and Action Questionnaire-II (AAQ-II).
Measured: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from quality of life
Quality of life measured by the ECORTC QLQ C-30.
Measured: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from symptoms
Symptoms measured by the EORTC QLQ-OV28.
Measured: within 3 weeks after the last day of self-monitoring (window: 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Neoplasm ; Psychological DistressStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813001
- Sponsor's protocol ID
- 4-2024-1286
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of ACT (Acceptance and Commitment Therapy)-Based Nurse-led Intervention for Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT06813001
- Acronym / sponsor ID
- 4-2024-1286
- Keywords
- Ovarian Neoplasms, Psychological Distress, Acceptand and Commitment Therapy (ACT), Nursing intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasiblity and effectiveness of an Acceptance and Commitment Therapy (ACT)-based nursing intervention aimed at managing psychological flexibility, distress, anxiety, depression, fear of cancer recurrence/progression, quality of life, and symptoms. Patients will participate in a single online session with a nurse, followed by a daily self-monitoring survey online for one week. Data will be collected at baseline (prior to the ACT session), on day 8 (after one week of self-monitoring), and at 5 weeks. Primary outcome is psychological flexibility.
Detailed description
This study is a preliminary single-group pre-post design aimed at developing and evaluating the feasibility of an ACT-based nursing intervention for distress management in patients with ovarian cancer. A total of 25 ovarian cancer patients who consent to participate will be enrolled in the study. Paticipants will receive a one-time ACT-based nursing intervention lasting approximately 60 minutes.
The researcher will coordinate schedules with participants to deliver the ACT-based nursing intervention using Zoom, a video conferencing platform which minimizes time and location constraints. Before the intervention, the research will ensure that the participants' video conferencing is working properly to minimize potential difficulties during the session.
Following the single-session intervention, the researcher will send a daily Google Form link to participants for seven consecutive days. Participants will be encouraged to access the link and complete self-monitoring surveys to reinforce the key components addressed in the program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: ACT-based nursing interventionExperimental group with application of ACT-based nursing intervention |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult (19 ≤ age ≤ 75).
- ovarian cancer patients with FIGO stage 2-3.
- Those who have completed first-line chemotherapy for ovarian cancer (excluding maintenance therapy) within the past 2 years.
Key exclusion criteria (2 listed)
- Patients with cognitive problems such as dementia or psychiatric problems such as major depression or generalized anxiety, or who are actively receiving treatment for any of these conditions.
- Patients with history of cancer recurrence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-based nursing interventionACT-based nursing intervention is a 1:1 single online session with a nurse, which takes about 60 minutes followed by a daily self-monitoring survey for one week, which encourages patients to practice ACT. | Other | A |
Primary outcome
Change from baseline psychological distress on the last day of self-monitoring (Day 8)
Time frame: Psychological distress will be assessed at baseline and on the last day of self-monitoring (Day 8).
Psychological distress measured by Distress Thermometer.
6 secondary outcomes
Change from baseline depression
Time frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from anxiety
Time frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from fear of cancer recurrence
Time frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from psychological flexibility
Time frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from quality of life
Time frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Change from symptoms
Time frame: within 3 weeks after the last day of self-monitoring (window: 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Ovarian Neoplasm ; Psychological Distress
Recruiting
Feasibility of CALM in Patients With Ovarian Cancer
Patient Satisfaction, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-based nursing intervention in people with Ovarian Neoplasm ; Psychological Distress, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyeon Lee, RN, NP, Ph.D (82-2-2228-3255, jiyeonest@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline psychological distress on the last day of self-monitoring (Day 8) (time frame: Psychological distress will be assessed at baseline and on the last day of self-monitoring (Day 8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.